NCT03864003

Brief Summary

The purpose of this study is to test the feasibility of a teleaudiology intervention with assistance from Community Health Workers to improve access to hearing health care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 6, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

October 30, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2020

Completed
Last Updated

May 17, 2022

Status Verified

May 1, 2022

Enrollment Period

5 months

First QC Date

March 3, 2019

Last Update Submit

May 15, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Self-efficacy: The Self-Efficacy for Situational Communication Management Questionnaire

    The Self-Efficacy for Situational Communication Management Questionnaire (Jennings, 2005; Jennings et al, 2014) measures self-perceived hearing ability and hearing self-efficacy, or a participant's beliefs in their ability to manage communication with acquired hearing loss. The SESMQ contains 20 situations that are rated on two scales, hearing ability and perceived self-efficacy. Participants respond on a Likert scale from 0 (not well at all) to 10 (very well) to how well they can hear and how well they can manage in each situation. Total scores on each scale range from 0-200, with higher scores representing better perceived self-efficacy and better hearing ability. The two scales are scored and reported separately. We will evaluate the differences in SESMQ scores between experimental and control groups at 2-weeks post hearing aid fitting. Analyses will utilize baseline data and follow-up analyses will occur for 6-week and 12-week timepoints.

    Baseline, 2 weeks, 6 weeks, and 12 weeks after hearing aid fitting

Secondary Outcomes (5)

  • Hearing aid benefit

    Baseline, 6 weeks, and 14 weeks after hearing aid fitting

  • Satisfaction with teleaudiology service delivery

    2 weeks after hearing aid fitting

  • Qualitative outcomes via semi-structured interviews

    14 weeks after hearing aid fitting

  • Average hours of hearing aid usage per day

    2 weeks, 6 weeks, 14 weeks after hearing aid fitting

  • Subjective hearing aid benefit

    2 weeks, 6 weeks, 14 weeks after hearing aid fitting

Study Arms (2)

Experimental group

EXPERIMENTAL

Participants randomized to the experimental group will receive hearing aid fitting and verification services via teleaudiology with local, hands-on support from a Community Health Worker.

Behavioral: Community Health Workers and Teleaudiology as a Culturally-Relevant Approach to Improving Access to Hearing Health Care

Control Group

ACTIVE COMPARATOR

Participants randomized to the control group will receive hearing aid fitting and verification services via teleaudiology with local, hands-on support from a non-Community Health Worker (undergraduate student in Speech, Language, and Hearing Sciences).

Behavioral: Community Health Workers and Teleaudiology as a Culturally-Relevant Approach to Improving Access to Hearing Health Care

Interventions

In this project, remote hearing aid fittings will be delivered by an audiologist with patient-site support from a local facilitator for a cohort of older adults (\>50 years) from a rural area that has been identified as under-resourced for hearing health care.

Control GroupExperimental group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Bilateral hearing loss within the fitting range of study hearing aids

You may not qualify if:

  • Medically unqualified to receive hearing aids
  • Current hearing aid user
  • Cognitively impaired

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mariposa Community Health Center

Nogales, Arizona, 85621, United States

Location

Related Publications (2)

  • Coco L, Leon K, Navarro C, Piper R, Carvajal S, Marrone N. "Close to My Community": A Qualitative Study of Community Health Worker-Supported Teleaudiology Hearing Aid Services. Ear Hear. 2024 Sep-Oct 01;45(5):1191-1201. doi: 10.1097/AUD.0000000000001507. Epub 2024 May 30.

  • Marrone NL, Nieman CL, Coco L. Community-Based Participatory Research and Human-Centered Design Principles to Advance Hearing Health Equity. Ear Hear. 2022 Jul-Aug 01;43(Suppl 1):33S-44S. doi: 10.1097/AUD.0000000000001183. Epub 2020 Jun 13.

MeSH Terms

Conditions

Hearing Loss

Interventions

Community Health Workers

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Allied Health PersonnelHealth PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Laura S Coco, AuD

    University of Arizona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 3, 2019

First Posted

March 6, 2019

Study Start

October 30, 2019

Primary Completion

March 27, 2020

Study Completion

June 4, 2020

Last Updated

May 17, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations